ART MEDICAL Ltd
  • Published: September 20, 2021
Category
Job Type
Level of education
High school
Spoken Language needed
English
Level of Hebrew
Medium
Location of job
Netanya
How many relevant years experience do you require for the role:
More than 3 years

Description

ART MEDICAL is a well-funded, medical startup developing cutting-edge technologies for ICU patients. Our smART+™ platform is an intelligent, sensor-based feeding system for critical care patients that aims to prevent life-threatening in-hospital complications such as ventilator-associated pneumonia, malnutrition, and acute kidney injury. With the introduction of Nutrition Management 2.0™ to critical care patient scoring systems, the smART+™ platform monitors analyze, and prevents malnutrition and gastric aspiration in real-time. By providing optimal nutritional care and achieving up to 100% feeding efficiency, the smART+™ platform improves the standard of care and helps ICU patients recover faster.

- Regulatory responsibilities associated with the development, support, and manufacturing of the Company’s medical device products (including compliance).
- Supervise and manage Regulatory Affairs tasks: managing day-to-day workload and operational issues.
- Provide training, coaching, support, and acting as a point of escalation where necessary for Regulatory Affairs Specialists.
- Responsibility for implementing regulatory requirements for post-market surveillance and clinical in accordance with ISO13485, EU MDR 2017/745 and other jurisdictions as required.
- Preparation / Review of responses to global regulators in relation to Post Market Surveillance, Post-Market Clinical Follow-Up, Clinical Evaluation, Summaries of Safety and Clinical Performance.
- Ensure Post Market Surveillance and Clinical Evaluation are conducted to schedule.
- Initiate regulatory documentation and ensure they completion for pre-market products, as per the design control process and procedures.
- Ensure global requirements are met and relevant regulatory guidance documents identified.
- Participate in internal and external audits as Subject Matter Expert in Post Market Surveillance and Clinical
- Actively pursues ways in which to improve the function of the Regulatory Affairs Department supporting continuous improvement activities.
- Identify and interpret relevant regulatory guidelines.

Requirements

- Minimum of 5 years experience in regulatory affairs in the Medical Device industry
- must understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes. 
- Scientific, medical, or technical background or relevant industry experience
- Excellent English
- Excellent problem-solving, judgment, and decision-making skills
- Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.

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